A Study to Evaluate REbamiPide as an Adjuvant Regimen to Heal erosIve Reflux Esophagitis

Overview

The purpose of this study is to evaluate whether Rebamipide facilitate the healing of inflamed mucosa as an adjuvant regimen in erosive reflux esophagitis (ERE).

Full Title of Study: “A Multicenter, Randomized, Double-blinded, Placebo-controlled Pilot Study to Evaluate the Efficacy and Safety of Rebamipide as an Adjuvant Regimen to Heal erosIve Reflux Esophagitis (REPAIR)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: January 2016

Detailed Description

1. To evaluate whether Rebamipide facilitate the healing of inflamed mucosa as an adjuvant regimen in erosive reflux esophagitis patients 2. To evaluate the safety of rebamipide as an adjuvant regimen in erosive reflux esophagitis (ERE)

Interventions

  • Drug: Lansoprazole
    • Oral administration of Lanston® (lansoprazole) 30 mg, 1 capsule, PO, qd, 30 min before breakfast
  • Drug: Rebamipide
    • Oral administration of Mucosta (rebamipide) 100 mg, 1 tablet, PO, tid, 30 minutes before breakfast, lunch, and dinner
  • Drug: Rebamipide-placebo
    • Oral administration of Mucosta®-placebo, 1 tablet, PO, tid, 30 minutes before breakfast, lunch and dinner

Arms, Groups and Cohorts

  • Experimental: Study Group
    • Lanston® (lansoprazole) 30 mg, 1 capsule, PO, qd, 30 min before breakfast Mucosta® (rebamipide) 100 mg, 1 tablet, PO, tid, 30 minutes before breakfast, lunch and dinner
  • Placebo Comparator: Control Group
    • Lanston® (lansoprazole) 30 mg, 1 capsule, PO, qd, 30 min before breakfast Mucosta®-placebo (rebamipide-placebo), 1 tablet, PO, tid, 30 minutes before breakfast, lunch and dinner

Clinical Trial Outcome Measures

Primary Measures

  • Endoscopic healing rate
    • Time Frame: 4 weeks
    • The ratio of the endoscopically completely healed (normal or minimal change) patients per groups

Secondary Measures

  • Histologic change
    • Time Frame: 4 weeks
    • Histologic change defined with Hematoxylin and eosin (H&E) stain
  • Change in inflammatory cytokines
    • Time Frame: 4 weeks
    • Change in the tissue level of Platelet activating factor (PAF) and Interleukin-8 (IL-8)
  • Time to complete symptom relief
    • Time Frame: every 2 week, up to 4 week
    • Interval between inital medication and the first time of symptom relief judged by subject’s diary
  • Overall symptom relief
    • Time Frame: every 2 week, up to 4 week
    • The proportion of relieved subjects at the end of treatment
  • Adverse events profile
    • Time Frame: every 2 week, up to 4week
    • patient’s symptoms, physical findings, abnormal laboratory values, vital signs, and ECG findings

Participating in This Clinical Trial

Inclusion Criteria

1. Male/female patients aged 20 to 70 at the time of writing an informed consent. 2. Subjects who were diagnosed with Erosive Reflux Esophagitis (ERE) using Los Angeles (LA) classification grade A~D, confirmed by endoscopy. 3. The subjects regardless of presence of ERE symptom (i.e., symptomatic ERE or asymptomatic ERE). For symptomatic ERE, the subject must have one or more symptoms of the followings: acid regurgitation, heartburn, epigastric pain, cough, hoarseness, globus pharyngis, atypical chest pain. 4. Subjects who have consented to participate in this clinical study by signing an informed consent form. Exclusion Criteria:

1. Patients with known hypersensitivity to any component of Lanston® and/or Mucosta® formulations. 2. Other concurrent organic upper gastroesophageal disease in endoscopy (i.e., drug-induced esophagitis, viral esophagitis, Mallory-Weiss syndrome, peptic ulcer disease, malignancies) and patients who was diagnosed with Barrett's esophagus. 3. History of abdominal surgery that can affect gastrointestinal motility (except appendectomy and hysterectomy). 4. History of upper gastrointestinal bleeding or obstruction. 5. Patients administrated with any drugs that can affect the efficacy of study regimen (proton pump inhibitors, revaprazan, prokinetics, H2-blockers, etc.) within 2 weeks (however, 4 weeks for PPIs) prior to enrollment and/or those who are required of NSAIDs, anti-coagulants, anti-cholinergics, prostaglandin E, corticosteroids, and anti-depressants treatment during the study period. 6. History of pancreatobiliary disease (except asymptomatic gallbladder stone), inflammatory bowel disease, cirrhotic liver disease, chronic kidney disease. 7. Pregnant, nursing, and childbearing potential women who is unwilling to effective contraception; for example, oral contraceptives, hormonal methods, placement of an intrauterine device (IUD) or intrauterine system (IUS), barrier methods (i.e., condom or occlusive cap with spermicidal foam/gel/film/cream/suppository), male sterilization, and true abstinence. 8. History of psychological disorder, alcoholics, and drug abuser. 9. Blood test results of hemoglobin (Hb) ≤ 10.0 g/dL, platelets ≤ 50,000 /µL, total WBCs ≤ 4,000/µL or ≥ 10,000/µL, and with serum test results showing the levels of AST, ALT, ALP, BUN, and creatinine exceeding twice the normal range of respective institution. 10. Patients who previously underwent another clinical survey within 4 weeks. 11. History of major medical disease that can affect general condition and other patients deemed not eligible for this study by investigators.

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • YongChan Lee
  • Collaborator
    • Otsuka Pharmaceutical Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: YongChan Lee, Professor – Severance Hospital
  • Overall Official(s)
    • Yong Chan Lee, MD, PhD, Principal Investigator, Severance Hospital, Yonsei University Health System
    • Seong Woo Jeon, MD, PhD, Principal Investigator, Kyungpook National University Medical Center
    • Su Jin Hong, MD, PhD, Principal Investigator, Soonchunhyang University Buchen Hospital
    • Kyung Ho Song, MD, Master, Principal Investigator, Konyang University Hospital
    • Shiming Yang, MD, PhD, Principal Investigator, Xinqiao Hospital of Chongqing

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Citations Reporting on Results

Holzheimer RG, Mannick JA, editors. Surgical Treatment: Evidence-Based and Problem-Oriented. Munich: Zuckschwerdt; 2001.

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